Centralized Study Spec I in Bangalore, भारत

Fortrea seeks a Centralized Study Spec professional to support clinical trial operations in Bangalore. The role involves reviewing study documentation, managing informed consent forms, ensuring regulatory compliance, and coordinating with internal and sponsor teams to meet submission deadlines.

Responsibilities

• Review and implement study-specific plans and protocols for assigned tasks
• File task-related documentation in the Electronic Trial Master File (eTMF)
• Review country and site ICFs for regulatory and sponsor compliance
• Liaise with local teams and sponsors to ensure timely ICF approvals
• Conduct quality checks and support process improvement initiatives

Requirements

• University degree in life science or allied health certification
• 3-5 years clinical research work experience
• Knowledge of ICH, FDA, IRB/IEC regulations and GCP guidelines
• Proficiency in MS Office applications
• Strong written and oral communication abilities
• Excellent organizational and proofreading skills